Ji Shen: Dr.Ma Shuangcheng,Director of Institutes for Control of Chinese Traditional Medicines and Ethnic Medicine,National Institutes for Food and Drug Control,is a long-term researcher on the quality standards of Ch...Ji Shen: Dr.Ma Shuangcheng,Director of Institutes for Control of Chinese Traditional Medicines and Ethnic Medicine,National Institutes for Food and Drug Control,is a long-term researcher on the quality standards of Chinese materia medica,Chairman Member of the Risk Assessment of the Pharmacopoeia of People's Republic of China ,and is also the Director Member of the Professional Committee of Drug Risk,China Pharmaceutical Association,and the Director Member of the Directors Committee of Chinese Materia Medica Quality and Safety.He has long been engaged in the control of the quality and safety of Chinese materia medica,and has also been included in the National 10000 Talent Plan.Let's invite Dr.Ma to give a report.Thank you.展开更多
Current China Pharmacopoeia(ChP)standards employ diversified and case-dependent assay methods to evaluate the quality of different Chinese patent medicines(CPM)that contain Panax notoginseng as the monarch drug.These ...Current China Pharmacopoeia(ChP)standards employ diversified and case-dependent assay methods to evaluate the quality of different Chinese patent medicines(CPM)that contain Panax notoginseng as the monarch drug.These conventional HPLC-based approaches utilizing complex sample preparation procedure can easily result in low analytical efficiency and possible component loss.We thereby propose a'monomethodheterotrait matrix'(MHM)展开更多
Objective:Huamaoyan Granules(HMYG)and Huamaoyan Capsules(HMYC)are Chinese patent medicines with different dosage forms of the same prescription.Due to the different preparation process,the chemical composition of thes...Objective:Huamaoyan Granules(HMYG)and Huamaoyan Capsules(HMYC)are Chinese patent medicines with different dosage forms of the same prescription.Due to the different preparation process,the chemical composition of these Chinese patent medicines varies greatly among different forms,but there were few studies on the difference comparison and quality control of them.In order to improve the effectiveness and safety in its clinical application,an idea combining high performance liquid chromatography(HPLC)and chemometrics was put forward to study the quality control of Chinese patent medicines in different dosage forms of the same prescription.Methods:The differential markers of HMYG and HMYC were explored based on HPLC fingerprint and chemometrics including orthogonal projections to latent structures-discriminant analysis(OPLS-DA),principal component analysis(PCA),and hierarchical cluster analysis(HCA).Finally,the quantitative analysis method of related components was established by HPLC.Results:A quality control method for HMYG and HMYC was established.Firstly,the chemical components of HMYG and HMYC were systematically analyzed by HPLC fingerprinting.Further exploration showed that there were 20 characteristic peaks and 57 common peaks.Then,the potential differential markers between HMYG and HMYC were explored by chemometrics,and the differential markers were screened after intersection with the 20 characteristic peaks.Finally,HPLC quantitative analysis methods for nine components were established,including seven differential markers(neochlorogenic acid,protocatechualdehyde,chlorogenic acid,cryptochlorogenic acid,caffeic acid,rosmarinic acid and salvianolic acid A).The results of HPLC quantitative analysis showed that the contents of eight components in HMYG and HMYC samples were significantly different.According to the above results,the differential markers between HMYG and HMYC screened based on HPLC fingerprint and chemometrics can effectively characterize the differences between the two dosage forms.Conclusion:The present work provides a rapid and effective method for routine quality evaluation and control of HMYG and HMYC.This work also provides feasible methods for the quality evaluation and control of Chinese patent medicines with different dosage forms of the same prescription.展开更多
文摘Ji Shen: Dr.Ma Shuangcheng,Director of Institutes for Control of Chinese Traditional Medicines and Ethnic Medicine,National Institutes for Food and Drug Control,is a long-term researcher on the quality standards of Chinese materia medica,Chairman Member of the Risk Assessment of the Pharmacopoeia of People's Republic of China ,and is also the Director Member of the Professional Committee of Drug Risk,China Pharmaceutical Association,and the Director Member of the Directors Committee of Chinese Materia Medica Quality and Safety.He has long been engaged in the control of the quality and safety of Chinese materia medica,and has also been included in the National 10000 Talent Plan.Let's invite Dr.Ma to give a report.Thank you.
文摘Current China Pharmacopoeia(ChP)standards employ diversified and case-dependent assay methods to evaluate the quality of different Chinese patent medicines(CPM)that contain Panax notoginseng as the monarch drug.These conventional HPLC-based approaches utilizing complex sample preparation procedure can easily result in low analytical efficiency and possible component loss.We thereby propose a'monomethodheterotrait matrix'(MHM)
基金supported by Shineway Pharmaceutical Group Ltd.(No.2020110031006073).
文摘Objective:Huamaoyan Granules(HMYG)and Huamaoyan Capsules(HMYC)are Chinese patent medicines with different dosage forms of the same prescription.Due to the different preparation process,the chemical composition of these Chinese patent medicines varies greatly among different forms,but there were few studies on the difference comparison and quality control of them.In order to improve the effectiveness and safety in its clinical application,an idea combining high performance liquid chromatography(HPLC)and chemometrics was put forward to study the quality control of Chinese patent medicines in different dosage forms of the same prescription.Methods:The differential markers of HMYG and HMYC were explored based on HPLC fingerprint and chemometrics including orthogonal projections to latent structures-discriminant analysis(OPLS-DA),principal component analysis(PCA),and hierarchical cluster analysis(HCA).Finally,the quantitative analysis method of related components was established by HPLC.Results:A quality control method for HMYG and HMYC was established.Firstly,the chemical components of HMYG and HMYC were systematically analyzed by HPLC fingerprinting.Further exploration showed that there were 20 characteristic peaks and 57 common peaks.Then,the potential differential markers between HMYG and HMYC were explored by chemometrics,and the differential markers were screened after intersection with the 20 characteristic peaks.Finally,HPLC quantitative analysis methods for nine components were established,including seven differential markers(neochlorogenic acid,protocatechualdehyde,chlorogenic acid,cryptochlorogenic acid,caffeic acid,rosmarinic acid and salvianolic acid A).The results of HPLC quantitative analysis showed that the contents of eight components in HMYG and HMYC samples were significantly different.According to the above results,the differential markers between HMYG and HMYC screened based on HPLC fingerprint and chemometrics can effectively characterize the differences between the two dosage forms.Conclusion:The present work provides a rapid and effective method for routine quality evaluation and control of HMYG and HMYC.This work also provides feasible methods for the quality evaluation and control of Chinese patent medicines with different dosage forms of the same prescription.
文摘目的评价复方丹参滴丸、复方丹参片、速效救心丸、通心络胶囊与硝酸异山梨酯治疗冠心病心绞痛随机对照试验(randomized controlled trial,RCT)质量。方法检索电子数据库并筛选出符合纳入标准的RCT。采用Jadad评分量表、M评分量表、CONSORT2010、CONSORT for herbal medicine评价报告质量。利用R统计软件对RCT质量与其基本特征(作者数量、发表年限、样本量、疗程)之间的Kendall相关性进行分析计算。结果 88篇RCT报告纳入研究分析。各评价标准得分中位数(平均值,95%可信区间)分别为Jadad评分量表2.00(2.09,[1.81,2.37])、M评分量表4.00(3.52,[2.95,4.09])、CONSORT201015.00(15.39,[13.87,16.91])和CONSORT for herbal medicine19.00(19.06,[17.16,20.96])。Jadad得分>2的高质量报告只有9.1%(8/88)。纳入研究的RCT质量与提取出的基本特征未呈显著相关。结论中成药对比硝酸异山梨酯治疗冠心病心绞痛RCT的质量1997-2009年没有显著改善。需要努力提高RCT的设计实施与报告质量。
